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Synthetic Biologics Nabs C. difficile Infectious Disease Program

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Synthetic Biologics entered into an agreement with Prev AbR to acquire its clinical-stage and related beta-lactamase assets targeted for the prevention of Clostridium difficile infection. The assets include a pre- (IND package, Phase I and Phase II clinical data, manufacturing process data, and all issued and pending U.S. and international patents intended to support an IND and BLA with the FDA.

According to the companies, beta-lactamase enzymes have the ability to degrade beta-lactam antibiotics that may be excreted into the GI tract. Utilizing the acquired compounds, Synthetic Biologics intends to develop and commercialize an oral beta-lactamase enzyme product candidate, SYN-004. When co-administered with beta-lactam antibiotics in a hospital setting, it is expected that SYN-004 can preserve a patient's gastrointestinal microflora, thus preventing opportunistic C. diff infection (CDI).

The acquisition includes the clinical-stage and related beta-lactamase assets, P1A, P2A and P3A (now known as SYN-004). Phase I studies of P1A, the first compound in the series, showed acceptable safety and tolerability. In addition, two Phase II clinical studies demonstrated its ability to preserve GI microflora in hospitalized patients treated with intravenous ampicillin or the combination of piperacillin and tazobactam.

"We are pleased to add the C. diff program to our infectious disease pipeline that also includes an acinetobacter infection program. The need for an alternative mechanism of action to prevent the devastating effects of C. diff infection is critical. It is important to both improve patient care and to combat the burden of rising medical costs associated with hospital-acquired infections such as C. diff," stated Jeffrey Riley, CEO. "With regulatory discussions already initiated, we are designing a regulatory pathway for our new product, SYN-004, that is intended to lead to a Phase II clinical trial as soon as possible. We look forward to reporting progress from our C. diff program when milestones are achieved."

At the end of October, the company completed a $10.8 million private placement financing intended to fund its monoclonal antibody and synthetic DNA programs, as well as expand its pipeline.

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